Roller compaction: Ribbon splitting and sticking

Mahmah, Osama; Adams, M.J.; Omar, Chalak S.; Gururajan, Bindhu; Salman, Agba D.

doi:10.1016/j.ijpharm.2019.01.031

Cited by 12 publications

(4 citation statements)

References 39 publications

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“…al. 's research, two splitting patterns are most common among all situations: transversally (through the ribbon thickness) or longitudinally (through the ribbon width) [4]. Transversal splitting is always associated with the lack of lubrication, but longitudinal splitting is far more complex: it is associated with the uneven distribution of ribbon density and the yield strength of the ribbon.…”

Section: Challengesmentioning

confidence: 99%

Research on the challenges and improvements of the roller compaction process for dry granulation

Shen

2023

ACE

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The analysis of the challenges for roller compaction (RC) in the dry granulation (DG) pharmaceutical industry process and their relative improvements are presented based on the review of previous research done by others. According to research between the 2000s and 2010s, magnifying the benefit that already obtains has been the main improvement of RC, such as increasing production efficiency and stability. Although modifications also reduced some of the disadvantages, such as reducing the use of raw material and waste, these improvements are still too limited, and some serious limitations still hindered the application of RC: the three major issues were: the large number of fragments producing, relatively fragile tablet, and the easy breaking ribbon. However, some research that took place later quickly fixed the limitation and make RC more applicable. This review briefly summarizes the issues that exist in the RC process, the improvements that have already been done to improve RC, and the limitations that RC still has.

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Section: Challengesmentioning

confidence: 99%

Research on the challenges and improvements of the roller compaction process for dry granulation

Shen

2023

ACE

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“…Ribbon splitting may occur transversally (through the ribbon thickness) or longitudinally (through the ribbon width) [74]. Table S1 was constructed to better display the splitting characteristics of ribbons produced under different pressures.…”

Section: The Ribbon Characteristicsmentioning

confidence: 99%

“…The transverse splitting is reported to have an adverse effect on the performance of the RC process, since the ribbon may adhere to the roller surface [74]. For Category I materials, a total of 141 tangible ribbon samples were prepared, and only 29 ribbons displayed the transversal splitting.…”

Section: Roll Compaction Behavior Classification Systemmentioning

confidence: 99%

Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction

Zhang

et al. 2019

Pharmaceutics

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The purpose of this study is to use a material library to investigate the effect of raw material properties on ribbon tensile strength (TS) and solid fraction (SF) in the roll compaction (RC) process. A total of 81 pharmaceutical materials, including 53 excipients and 28 natural product powders (NPPs), were characterized by 22 material descriptors and were compacted under five different hydraulic pressures. The transversal and longitudinal splitting behaviors of the ribbons were summarized. The TS-porosity and TS-pressure relationships were used to explain the roll compaction behavior of powdered materials. Through defining the target ribbon quality (i.e., 0.6 ≤ SF ≤ 0.8 and TS ≥ 1 MPa), the roll compaction behavior classification system (RCBCS) was built and 81 materials were classified into three categories. A total of 24 excipients and five NPPs were classified as Category I materials, which fulfilled the target ribbon quality and had less occurrence of transversal splitting. Moreover, the multivariate relationships between raw material descriptors, the hydraulic pressure and ribbon quality attributes were obtained by PLS regression. Four density-related material descriptors and the cohesion index were identified as critical material attributes (CMAs). The multi-objective design space summarizing the feasible material properties and operational region for the RC process were visualized. The RCBCS presented in this paper enables a formulator to perform the initial risk assessment of any new materials, and the data modeling method helps to predict the impact of formulation ingredients on strength and porosity of compacts.

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“…Granule quality can be measured by attributes, such as particle size distribution, granule hardness, bulk density, tapped density, uniformity, moisture content and flowability [9,10]. Unlike wet granulation, dry granulation is the process of agglomerating particles under pressure without the addition of a binding solvent [11]. Most dry granulation processes are performed using roller compactors [12,13].…”

Section: Introductionmentioning

confidence: 99%

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

et al. 2020

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In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing process involves various unit operations, such as blending, granulation, milling, tableting and coating and the process parameters of a unit operation have significant effects on the quality of the drug product. Depending on the change in batch scale, various process parameters should be strategically controlled to ensure consistent quality attributes of a drug product. In particular, the granulation may be significantly influenced by scale variation as a result of changes in various process parameters and equipment geometry. In this study, model-based scale-up methodologies for pharmaceutical granulation are presented, along with data from various related reports. The first is an engineering-based modeling method that uses dimensionless numbers based on process similarity. The second is a process analytical technology-based modeling method that maintains the desired quality attributes through flexible adjustment of process parameters by monitoring the quality attributes of process products in real time. The third is a physics-based modeling method that involves a process simulation that understands and predicts drug quality through calculation of the behavior of the process using physics related to the process. The applications of these three scale-up methods are summarized according to granulation mechanisms, such as wet granulation and dry granulation. This review shows that these model-based scale-up methodologies provide a systematic process strategy that can ensure the quality of drug products in the pharmaceutical industry.

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Roller compaction: Ribbon splitting and sticking

Cited by 12 publications

References 39 publications

Research on the challenges and improvements of the roller compaction process for dry granulation

Research on the challenges and improvements of the roller compaction process for dry granulation

Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

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